MAUDE Adverse Event Report: ROCHE DIAGNOSTICS NH3L AMMONIA; ENZYMATIC METHOD, AMMONIA

Model Number C501

Device Problem High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/28/2018

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).(b)(4).

Event Description

The customer stated that they received questionably high results for an unspecified number of patient samples tested for nh3l ammonia (nh3) on a cobas 6000 c (501) module - c501.Samples will repeat in normal ranges.The customer provided data for one patient sample which had an erroneous nh3 result that was reported outside of the laboratory.The sample initially resulted as 193.5 ug/l.The value was reported outside of the laboratory to the doctor, who asked for a rerun of the sample since the value was not compatible with the patient's clinical history.The sample was repeated on the same analyzer, resulting as 33.1 ug/dl.The sample was also repeated on a second c501 analyzer, resulting as 30.6 ug/l.No adverse events were alleged to have occurred with the patient.The nh3 reagent lot number was 273314, with an expiration date of 31-mar-2019.The last calibration performed on (b)(6) 2018 was flagged with an error.Quality control recovery was not stable, but was within range on the date of the event.Several abnormal probe aspiration alarms occurred on (b)(6) 2018.

Manufacturer Narrative

The customer installed a special wash on the analyzer for nh3.The issue was determined to be related to a reagent handling issue.Calibration and control data showed that contamination was likely.The customer loaded a new reagent lot and calibrated according to all handling instructions.Controls were acceptable.After 5 days of using the new reagent, the customer did not encounter any further issues.Unique identifier (udi)#: (b)(4).

• Brand Name: NH3L AMMONIA
• Type of Device: ENZYMATIC METHOD, AMMONIA
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7337229
• MDR Text Key: 103010519
• Report Number: 1823260-2018-00823
• Device Sequence Number: 1
• Product Code: JIF
• Combination Product (y/n): N
• PMA/PMN Number: K972250
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 03/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2019
• Device Model Number: C501
• Device Catalogue Number: 20766682322
• Device Lot Number: 273314
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1